On November 14, 2017 Delcath Systems, Inc. (OTCQB:DCTHD), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported financial results for the three and nine months ended September 30, 2017 (Press release, Delcath Systems, NOV 14, 2017, View Source;p=RssLanding&cat=news&id=2317164 [SID1234522086]).

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Highlights from the third quarter of 2017 and recent weeks include:

Revenue for the third quarter of 2017 increased 75% to $0.7 million from $0.4 million in the prior-year quarter;
Revenue for the first nine months of 2017 increased 53% to $2.0 million from $1.3 million in the prior-year period;
Medical University of Hannover achieved its 100th CHEMOSAT treatment milestone; over 450 commercial CHEMOSAT procedures have been performed in Europe;
Positive results from a single institution study of CHEMOSAT filtration efficiency were presented at 2017 CIRSE annual meeting in September; and
Reverse stock split effected at ratio of 1:350 on November 6, 2017.
Management Commentary

"During our third quarter, we focused on resolving the cash constraints and other restrictions related to our authorized shares limit, which necessitated the reverse stock split we effected on November 6, 2017. The authorized share limit prevented the Company from accessing the restricted cash otherwise available under our 2016 convertible notes. With the ability to issues shares now restored, we are able to access the balance of the restricted cash and begin exploring opportunities for new equity financing necessary to execute on our Clinical Development Program (CDP) and European commercialization," said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath.

"Despite the cash constraints, revenues for the third quarter of 2017 increased 75% over the prior year quarter, continuing the steady growth in our core European markets. This growth was supported by the establishment of ZE diagnostic-related (DRG) reimbursement for CHEMOSAT in Germany last year, which we are leveraging to obtain market access and reimbursement in other regions such as the United Kingdom and the Netherlands. In the Netherlands, Dutch Health Authorities have included CHEMOSAT treatment in their published guidelines for ocular melanoma liver metastases, an important step toward eventual reimbursement coverage of CHEMOSAT in the Dutch market. During the quarter, Medical University of Hannover performed their 100th treatment since beginning CHEMOSAT procedures in 2014, the second of our Europe centers to have achieved this milestone. Since launching CHEMOSAT in Europe, over 450 commercial CHEMOSAT procedures have been performed.

"In our Clinical Development Program (CDP), our primary focus continues to be on our FOCUS Phase 3 clinical trial of Melphalan/HDS in hepatic dominant ocular melanoma (the FOCUS trial). Enrollment in this trial has been proceeding more slowly than anticipated, and cash constraints during the quarter limited our ability to take steps to accelerate enrollment. With the reverse split effected we are exploring steps to accelerate enrollment, and will seek to add new trial sites in both the U.S. and Europe once new equity financing is secured. We still expect to conduct an interim safety analysis by the end of this year.

"For our pivotal trial in intrahepatic cholangiocarcinoma (ICC), we continue to work with potential trial sites with a view to initiating enrollment when financial resources permit. Our ICC pivotal trial is based on the prior work done in our Phase 2 trial program in hepatocellular carcinoma (HCC) and ICC, which had the objective of identifying an efficacy signal worthy of further clinical investigation. This objective was met by the retrospective data collection performed by European investigators last year, which informed our development path for ICC. With the Phase 2 trial program goals now met, we have closed enrollment in the Phase 2 trials to devote available resources to the FOCUS Trial and the ICC pivotal trial.

"Though the recent months have been financially difficult, we remain committed to advancing the clinical programs for our innovative Melphalan/HDS as well as to our commercialization efforts for CHEMOSAT in Europe. We are continuously working to advance our ability to operate so we can advance these important programs to increase value to our shareholders," concluded Dr. Simpson.

Three Month Financial Results

Revenue for the third quarter of 2017 was $0.7 million, an increase of 75% from $0.4 million for the third quarter of 2016. Selling, general and administrative expenses increased modestly to $2.9 million in the 2017 third quarter from $2.4 million in the prior-year third quarter. Research and development expenses for the third quarter of 2017 declined slightly to $2.3 million from $2.7 million in the prior-year quarter. Total operating expenses for the current quarter were $5.1 million compared with $5.0 million in the prior-year quarter.

The Company reported a net loss for the 2017 third quarter of $12.6 million, or $9.36 per share based on 1.4 million weighted average common shares outstanding on a split adjusted basis. This compares with a net loss in the prior-year period of $1.0 million, or $230.99 per share based on 4,349 weighted average common shares outstanding on a split adjusted basis. This increase in net loss is primarily due to an $8.7 million change in the fair value of the warrant liability and a $3.0 million loss related to two transactions to settle convertible note debt, both non-cash items.

Nine Month Financial Results

Revenue for the first nine months of 2017 was $2.0 million, an increase of 53% from $1.3 million for the first nine months of 2016. Selling, general and administrative expenses in the first nine months 2017 were approximately $7.8 million compared with $7.0 million in the prior-year period. Research and development expenses for the first nine months of 2017 increased to $7.1 million from $6.0 million in the first nine months of 2016. Total operating expenses for the first nine months of 2017 were approximately $15.0 million compared with $13.0 million in the prior-year quarter.

The Company recorded a net loss of $25.8 million for the first nine months of 2017, or $34.99 per share based on 754,421 weighted average common shares outstanding on a split adjusted basis. This compares with a net loss for the first nine months of 2016 of $9.5 million, or $2,232.30 per share based on 4,249 weighted average common shares outstanding on a split adjusted basis. The increase in net loss is due to an approximately $13.7 million increase in interest expense primarily related to the amortization of debt discounts and a $3.0 million loss related to two transactions to settle convertible note debt, offset by a $9.6 million gain on the extinguishment of the June 2016 Series C Warrants, both non-cash items. Additionally, there was a $1.9 million increase in operating expenses and a $7.9 million change in the fair value of the warrant liability, a non-cash item, offset by a $0.5 million increase in gross profit.

Balance Sheet Highlights

As of September 30, 2017, Delcath had cash and cash equivalents of $2.5 million, compared with $4.4 million as of December 31, 2016. In addition, the Company had $8.3 million in restricted cash primarily related to the Convertible Notes issued in June 2016. During the nine months ended September 30, 2017, the Company used $11.7 million of cash to fund operating activities. Management believes that its capital resources are adequate to fund operating activities through January 2018.

On November 14, 2017 Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that it has launched Clofarabine Injection, a therapeutic equivalent generic version of Clolar (clofarabine) Injection in the United States market, approved by the U.S. Food & Drug Administration (USFDA) (Press release, Dr Reddy’s, NOV 14, 2017, View Source [SID1234522026]).

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The Clolar brand and generic had U.S. sales of approximately $53 million MAT* for the most recent twelve months ended in September 2017, according to IMS Health*.

Dr. Reddy’s Laboratories’ Clofarabine Injection is available in single-dose, 20 mL flint vials containing 20 mg of clofarabine in 20 mL of solution (1mg/mL).

Clolar is a registered trademark of Genzyme Corporation.

*IMS National Sales Perspective: Retail and Non-Retail MAT September 2017
RDY-0217-146

Molecular Templates has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Molecular Templates, 2017, NOV 14, 2017, View Source [SID1234522056]).

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On November 14, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing investigational drugs for the treatment of orphan oncology indications, reported a corporate update and reported financial results for the three months ended September 30, 2017 (Press release, Mateon Therapeutics, NOV 14, 2017, View Source [SID1234522046]).

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Recent Corporate Highlights

Announced phase 1b data for OXi4503 in Study OX1222 for the treatment of relapsed/refractory acute myeloid leukemia/myelodysplastic syndromes, which show complete remissions and evidence of a dose response;
Elevated OXi4503 to lead program, representing the primary focus of Mateon’s drug development efforts; and
Terminated FOCUS Study in platinum-resistant ovarian cancer, terminated clinical development of CA4P, and restructured company down to six employees to reduce expenditures.
"OXi4503 destroys the protective environment that bone marrow tumors provide to AML stem cells while also simultaneously attacking the tumor cells themselves. Thus, if ultimately approved, our lead compound would be a completely new way to treat AML and should offer many advantages over other drugs currently on the market or in development for this indication," stated William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "With patent protection in AML to 2033, we believe that OXi4503 represents an outstanding business development or financing proposition, and are working to secure an arrangement that will allow us to accrue clinical data in higher-dose cohorts in Study OX1222."

Financial Results for the Third Quarter of 2017

For the three months ended September 30, 2017, Mateon reported a net loss of $3.5 million, compared to a net loss of $3.2 million for the three months ended September 30, 2016. Research and development expenses increased to $2.8 million for the three months ended September 30, 2017, compared to $2.1 million for the three months ended September 30, 2016, primarily due to higher clinical costs associated with the recently terminated FOCUS study. General and administrative expenses decreased to $0.7 million for the three months ended September 30, 2017, compared to $1.2 million for the three months ended September 30, 2016.

At September 30, 2017, Mateon had cash and short-term investments of $1.9 million.

"We very rapidly closed out the FOCUS Study in October. Following the other cost reductions implemented in late September, we now project that our existing cash, when combined with expected refunds from certain vendors, should sustain our OXi4503-focused business development and financing efforts into approximately February 2018," concluded Dr. Schwieterman.

On November 14, 2017 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported financial results for the three months ended September 30, 2017 and reported on corporate developments. Unless specified otherwise, all amounts are in Canadian dollars (Press release, Aptose Biosciences, NOV 14, 2017, View Source;p=RssLanding&cat=news&id=2316911 [SID1234522060]).

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The net loss for the quarter ended September 30, 2017 was $3.3 million ($0.14 per share) compared with $4.0 million ($0.31 per share) in the quarter ended September 30, 2016. Total cash and cash equivalents and investments as of September 30, 2017 were $13.6 million (or $10.9 million US dollars) which, based on current operations, provide the Company with sufficient resources to fund research and development and operations into Q4 2018.

"During the third quarter, we made important progress with both of our novel small molecule compounds for the treatment of certain hematologic malignancies," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "We’ve completed manufacture of high quality drug substance and explored multiple formulations of CG’806, our oral first-in-class pan-FLT3/pan-BTK inhibitor. We triggered PK and dose range finding studies with CG’806 in order to prepare the agent for advancement into the clinic for patients with acute myeloid leukemia and certain B-cell malignancies. We also generated renewed excitement about the potential for APTO-253, a clinical-stage compound that effectively inhibits expression of the c-Myc oncogene, and we believe we have effectively addressed the formulation and manufacturing setbacks that led to a clinical hold for APTO-253. Our goal is to return APTO-253 to the clinic for the treatment of patients with AML or MDS."

Corporate Highlights
Successful completion of APTO-253 formal root cause studies – Aptose successfully completed Formal Root Cause Studies for the manufacturing setback related to the clinical batch supply that failed stability testing and established a Corrective and Prevention Action (CAPA) plan.

Manufacture of APTO-253 clinical supply has begun – The Company has initiated the process to manufacture a cGMP clinical supply that will be required for a potential return of APTO-253 to the clinic. Upon manufacture of the new clinical supply, Aptose plans to perform stability, sterility, mock infusion, animal bridging and blood compatibility studies. Following completion of those studies, we would plan to submit findings to the FDA to seek release of the clinical hold and allow return of APTO-253 to the open Phase 1b trial in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

CG’806 manufacturing and preclinical testing progress – Aptose produced a highly purified batch of drug substance (API) to support pharmacokinetic (PK), formulation evaluation and dose range finding studies of CG’806. The PK and formulation evaluation studies have been completed, and the dose range finding preclinical studies are expected to begin before or shortly after year-end. Separately, the Company has initiated the process to manufacture multi-kilogram batches of GLP-grade API for use in the formal GLP/IND-enabling animal toxicity studies.

Intellectual property protection for CG’806 – During the third quarter, Aptose continued to strengthen its patent portfolio. In September, Aptose and partner CrystalGenomics announced that the United States Patent and Trademark Office issued U.S. Patent No. 9,758,508 which claims numerous compounds, including the CG’806 compound, pharmaceutical compositions comprising the CG’806 compound, and methods of treating various diseases. The patent is expected to provide protection until the end of 2033. In August, Aptose received notice allowing U.S. Patent Application No. 14/655,954. The allowed ‘954 application claims numerous compounds, including the CG’806 compound, pharmaceutical compositions comprising the CG’806 compound, and methods of treating various diseases caused by abnormal or uncontrolled activation of protein kinase in a mammal by administering a compound, including the CG’806 compound.

Strengthened financial position – The Company recently announced that it entered into a Common Shares Purchase Agreement with Aspire Capital Fund, LLC ("Aspire Capital") to sell up to US$15.5 million of common shares to Aspire Capital. Under the terms of the agreement, Aspire Capital made an initial investment of US$500,000 to purchase APTO common shares at US $1.40 per share on October 31, 2017. In addition, Aspire Capital has committed to purchase up to an additional US$15.0 million of APTO common shares, at Aptose’s request from time to time during a 30 month period beginning on the effective date of a registration statement related to the transaction, and at prices based on the market price at the time of each sale. Under terms of the agreement, the Company also issued 321,429 common shares to Aspire Capital as consideration for Aspire Capital entering into the Purchase Agreement.